- バリデーションガイド要約版
PureWeld® XL - high performance TPE tubing
PureWeld® XL - high performance TPE tubing is supported by an industry leading validation package and meets current industry requirements including:
- Meets or exceeds USP Class VI requirements
- Meets or exceeds ISO10993-1 requirements
- Meets or exceeds FDA regulations CFR177.1810 for contact with foods
- Full compendial data to USP <788> for sub-visible particulates
- EP 2.6.14, USP<85> for bacterial endotoxins, ISO 11737-1 for Bioburden
- Animal-derived content free (ADCF)
- Suitable for sterilisation by Gamma irradiation
Additional testing carried out includes extractables testing.
The full validation guide including additional information regarding test methods and actual test reports is available on request.
PureWeld XL, its raw materials and manufacturing process meets a number of regulatory compliance legislations. Specific statements relating to these compliances are available in the PureWeld XL compliance guide.
PureWeld XL additionally complies with the legal regulations laid down in the Regulation (EC) No. 1935/2004.
Both the full validation guide and the compliance guide can be requested by submitting the below form.
